[8-K] ProMIS Neurosciences Inc. Reports Material Event

Rhea-AI Filing Summary

On 21 Jul 2025 ProMIS Neurosciences (PMN) filed an 8-K disclosing two material items.

• ATM program terminated: The Company and BTIG mutually ended the US$25 m at-the-market agreement first signed 5 Jan 2024. Only 75,862 shares were sold for gross proceeds of US$190,274, leaving US$24.8 m unused. No termination penalties apply and no further shares will be issued under this facility.
• Pipeline progress: The FDA granted Fast Track Designation to PMN310, ProMIS’s lead monoclonal antibody for Alzheimer’s disease. A Data & Safety Monitoring Board has authorised escalation to the 10 mg/kg cohort in the ongoing Phase 1b trial, and, as of 21 Jul 2025, no amyloid-related imaging abnormalities (ARIA) have been observed.

The filing contains no financial results, but it removes potential equity dilution from the ATM, while regulatory momentum for PMN310 could shorten the development timeline.

Positive

• FDA Fast Track Designation for lead Alzheimer’s therapy PMN310, potentially accelerating approval timelines.
• No ARIA safety signals reported and clearance to escalate dosing in Phase 1b trial, indicating favorable safety profile.
• Mutually agreed termination of US$25 m ATM removes prospective share-sale overhang with no penalty.
• ATM usage was minimal (US$190k), meaning insignificant recent dilution for shareholders.

Negative

• Termination of ATM removes a US$24.8 m liquidity option, reducing near-term financing flexibility.
• Filing provides no update on cash runway, leaving investors uncertain about funding for later-stage trials.

Insights

Biotech Equity Analyst

TL;DR: Fast Track status and clean safety data materially de-risk PMN310 and strengthen PMN’s Alzheimer’s thesis.

Fast Track expedites FDA interactions, unlocking rolling review and potential priority approval pathways—valuable for a small-cap biotech. Zero ARIA events after first dose cohort lowers a key safety overhang seen with competing anti-amyloid antibodies. Dose-escalation approval signals positive safety signals and supports timely trial progression. Collectively, these developments enhance the asset’s probability of success and could attract partners or investors.

Capital Markets Analyst

TL;DR: Ending the US$25 m ATM reduces dilution risk but limits near-term financing flexibility.

The ATM was scarcely used, implying either limited market appetite or sufficient cash on hand. Termination eliminates overhang from future low-price issuances, a marginal positive for existing shareholders. However, with only US$0.19 m raised, management must rely on alternative capital sources—possibly costlier or more dilutive later—if trial costs rise. Net impact is neutral until balance-sheet details are disclosed.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 21, 2025

PROMIS NEUROSCIENCES INC.

(Exact name of registrant as specified in its charter)

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Ontario, Canada		001-41429		98-0647155
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

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Suite 200, 1920 Yonge Street, Toronto, Ontario				M4S 3E2
(Address of principal executive offices)				(Zip Code)

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Registrant’s telephone number, including area code: (416) 847-6898

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class		Trading Symbol(s)		Name of Each Exchange on Which Registered
Common Shares, no par value per share	​	PMN		The Nasdaq Capital Market

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter)

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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Item 1.01 Termination of a Material Definitive Agreement.

As previously disclosed, on January 5, 2024, ProMIS Neurosciences, Inc. (the “Company”) entered into an At The Market Offering Agreement (the “Agreement”) with BTIG, LLC, serving as agent (the “Agent”) with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, its common shares, no par value (the “Common Stock”), having an aggregate offering price of up to $25.0 million (the “Shares”) through the Agent (the “ATM Program”).

On July 21, 2025, the Company and BTIG mutually agreed to terminate the Agreement effective immediately as of July 21, 2025. The Company is not subject to any termination penalties related to the termination of the Agreement. Prior to termination, 75,862 of the Shares had been sold for gross proceeds of $190,274, and $24.8 million of the Shares remained available for sale pursuant to the Agreement. As a result of the termination of the Agreement, the Company will not offer or sell any additional shares under the ATM Program.

A copy of the Agreement was filed as Exhibit 1.1 to the Current Report on Form 8-K filed on January 5, 2024. The description of the Agreement contained in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the copy of the Sales Agreement filed as Exhibit 1.1 to the Current Report on Form 8-K.

Item 8.01 Other Events.

On July 21, 2025, the Company announced that the U.S. Food and Drug Administration granted Fast Track Designation to PMN310, the Company’s lead therapeutic candidate in development for the treatment of Alzheimer’s disease.

In addition, the Company received Data and Safety Monitoring Board approval to dose escalate into its second 10 mg/kg dose cohort in its PMN310 Phase 1b clinical trial in Alzheimer's patients in May 2025. As of July 21, 2025, the Company had not observed any cases of amyloid-related imaging abnormalities (ARIA), including brain swelling or microhemorrhages during the trial.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

​	PROMIS NEUROSCIENCES INC.
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Date: July 22, 2025	By:	/s/ Neil Warma
​	​	Name: Neil Warma
​	​	Title: Chief Executive Officer

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FAQ

What did ProMIS Neurosciences (PMN) announce in its latest 8-K?

Two events: termination of its US$25 m at-the-market equity program and FDA Fast Track status for Alzheimer’s candidate PMN310.

How many shares were sold under the terminated ATM program?

Only 75,862 common shares were sold, generating US$190,274 in gross proceeds.

What benefit does Fast Track Designation provide PMN310?

Fast Track offers more frequent FDA meetings, rolling data submission, and potential priority review, potentially shortening time to market.

Were any safety issues observed in the PMN310 Phase 1b trial?

As of 21 Jul 2025, no amyloid-related imaging abnormalities (ARIA) such as brain swelling or microhemorrhages have been observed.

Does the ATM termination incur any penalties for ProMIS?

No. The agreement was mutually terminated without penalties, effective 21 Jul 2025.

How does ending the ATM affect shareholder dilution?

Cancellation eliminates future issuances under the program, reducing the risk of ongoing dilution at market prices.